Anti-doping expert Parisotto on inherent delays in bio-passport system

Australian scientist Robin Parisotto has defended the length of time it takes for biological passport cases to advance through the various stages, cataloguing the complexity of the whole process in an interview with CyclingTips and saying that he considers the current Roman Kreuziger case to fit into the expected timeline.

The Tinkoff Saxo rider has been in the headlines since the end of June, when he and his team disclosed that he was under investigation for alleged biological passport irregularities. The Czech rider had been due to ride the Tour de France but was instead sidelined by his team, who later said the decision was taken in order to avoid negative publicity at the race plus extra stress for the riders on the squad.

Last week Tinkoff Saxo stated that, in the absence of a ruling by the UCI, it had decided to allow Kreuziger to return to competition and to compete in the Tour of Poland. Team owner Oleg Tinkov added on Twitter that he would take action of his own against the governing body.

“We’ll sue #UCI for non-disclosure that @Roman86_K had bio passport violations in 09/10 when we signed him in 2012.They knew, and hide this?,” he stated on Friday. “I lost millions of euro for not knowing this issue once the contract was cleared by UCI. Now, they have to pay us big bucks for this.”

The UCI responded on Saturday by saying that it was handed the rider a provisional sanction. This action blocked his return in Poland and suggests the case against the rider is at an advanced stage.

Tinkov’s claims of an unreasonable delay don’t appear to sync with the timeline relating to the Kreuziger case. The expert panel of the UCI’s Cycling Anti-Doping Foundation (CADF) concluded that Roman Kreuziger’s blood passport profile shows abnormalities relating to two periods; March 2011 until August 2011 plus April 2012 until the end of the 2012 Giro d’Italia.

However these patterns only became suspect in light of more ‘normal’ values detected since those dates. As a result of this the CADF sent a letter to Kreuziger dated June 28 2013, laying out its concerns and inviting the rider to explain the alleged irregularities.

This occurred six months into his contract with the Tinkoff Saxo team; as Parisotto explains below, the nature of the whole biological passport system plus the lack of the clear black and white situation seen with standard positive tests leads to a longer timeline before anomalies can be red-flagged.

After Kreuziger received the warning letter in June of last year, he sought expert opinions and presented two supporting his claims of innocence on October 3 2013.

The supporting documentation was looked into and considered, with the CADF’s expert panel deciding that his explanation wasn’t satisfactory. He was informed of this on May 30 of this year. He and his team both issued statements on June 28 announcing that the UCI was likely to formally open up disciplinary proceedings.

In the interview below, Parisotto – who was involved in inventing the first EPO test and who has been part of the bio passport expert panel for several years – details how the passport system works. While he spoke to CyclingTips prior to Tinkov’s threat to sue the UCI over delays, his explanation of the system explains why the type of quick decisions demanded by the Russian don’t fit in with the science behind the process, as well as the need to give riders ample time to defend themselves.

CyclingTips: We appreciate that you can’t say much about what is an ongoing situation, but can you explain in general why biological passport cases can take time to develop and to reach a conclusion?

Robin Parisotto: Sure. There are 900 cyclists in the pro peloton, so it is a pretty big job to compile all the data. In saying that, some riders will be tested more often than others. Some may only be tested once every three months, maybe once every six months. Others may be tested monthly.

It depends on what sort of results they have displayed in the past, and if there is a reason for them to be targeted? Are they high suspicion? That leads to someone to target test those particular athletes.

Some athletes will have many blood tests in a twelve month period, others may only have one or two. In a case like this [that of Roman Kreuziger – ed.] , it may well have been that he was tested in 2011 and 2012, and maybe there were only a handful of tests thereafter.

Perhaps it was only then that the body of knowledge which was accumulated and put together showed that there was a suspicious pattern. Unfortunately that is the way it is with the biological passport. It is not a one-off test, where you may simply test positive and then the case goes ahead. In this case you have to accumulate a great amount of detail. You have to cast your eye over perhaps years of data to see if there is some sort of pattern that is suspicious.

CT: So multiple data points are needed and it takes time to build those up?

RP: Yes, absolutely.

CT: Can you explain in brief how the whole process works, from start to finish?

RP: Sure. Initially the data will be fed into the WADA ADAMS system and then we will receive notification that there are X number of profiles to be reviewed. We will go in and review those profiles and we will make our assessments. Those comments will then go back through the ADAMS system to the UCI.

That takes time, because there are hundreds of profiles to be reviewed. Then following that, there will be a second opinion sought from a different expert, and if that expert then corroborates the initial evaluation or review or conclusion, then a teleconference will be arranged between the relevant experts to discuss that particular case.

They will decide on it. It has to be unanimous that there is evidence there for a case to proceed. Again, we are talking about time.

CT: What happens then?

RP: At the point in time when there is agreement between three experts that there is suspicion, the UCI or the APMU [Athlete’s Passport Management Unit] will then request what is known as a documentation package. In the case of the biological passport, it is not just seeking one documentation package, it could be seeking 60 documentation packages.

That may have to come from five or six different laboratories. Within that documentation package, you have got an enormous amount of information that is required. That would include doping control forms, it would include chain of custody forms, collection and transport and storage details, the analysis details, the results, the quality control data. So within a documentation package you may have anything up to 20 or 30 pages per test. And if you have got 50 or 60 tests, then you are talking a lot of paperwork that needs to be reviewed.

Once all of those documentation packages are put together, they are then sent back to the three experts. They will individually assess those packages and with that information, they will then review the profile and see if there is a doping scenario. They need to see if the results match what the documentation package details may reveal or not; whether it was pre competition, whether it was an in competition result, whether it was during the off season, whether it was in season. All that sort of stuff.

Once that documentation package is reviewed – and that can take weeks, because of the amount of data that needs to be reviewed – the experts will put together a report and that will go back and forwards for a number of weeks. As you may appreciate, you have to cross every T and dot every I in these cases.

A report is then compiled and it is signed off and sent back to the APMU. Then from there I would assume that there would be some sort of legal assessment of the response by the experts in moving forward with the case. I guess once they are happy with the scientific report – and they may have questions in the meantime, which we would have to address and then send back – once all of that is finalised, then that report or whatever is then provided to the athlete for that athlete to then respond to.

CT: So this all takes time. What happens at that point?

RP: In most cases, an athlete will seek an expert opinion, maybe two expert opinions. That can take a long time as well, two or three months, because it is really difficult to get an expert and just get them to drop everything to assess an individual case. Don’t forget most of those experts have day jobs.

Then that report will be then provided back to the APMU and they will then forward that back to us experts, and we will comment on that response. Once we have commented on that, it will then go back to the APMU for perhaps a final legal review. Then, based on our response to the athlete’s reply, and any legal questions, the APMU or the UCI would then be in a position to notify the athlete of the outcome of the review.

There will be one of two decisions made, based on the evidence: that the case will go forward, or that it will not progress.

As you can see, it is a very involved, complex and pretty long-winded way of doing things. But because you are not just reliant on one positive test result, but are reliant on a body of knowledge which reveal certain patterns, unfortunately that is the way it is with the passport.

CT: To jump right back to the very start and clarify how things start: initially one expert will determine that something looks suspicious, and he will then speak to another expert…

RP: Yes. The first expert will send their comments back through the WADA ADAMS system. I am not really sure what happens internally, but they will look through it and then they would send that out to a second expert for their comment.

There is no communication at that point in time between experts, because we don’t know what other expert and what other profiles are reviewing. The first time the experts actually talk together about a particular case is when there is a teleconference.

CT: And there are three experts then…

RP: Yes.

CT: Just to be clear – you have got expert A, then it goes via the APMU to expert B. Then you have a teleconference with three. Are experts A and B two of the three, or are they a separate three again?

RP: I am pretty sure they are the first two, then another.

CT: What is the typical length of time it takes to get from the start of that process to the point where a decision is made that there is indeed a case to answer? Is it something that typically takes about a year?

RP: Realistically it is. I can’t think of a case that I can remember when it has taken less than a year, when the initial review has taken place and the athlete is notified.

CT: So this situation with Roman Kreuziger isn’t that unusual. Okay, you have a March 2011 to August 2011 period, but then the second period is April 2012 to May 2012. Then the athlete was given an initial notification of 28th of June 2013. So that is just over a year – this is again it is within the typical timeframe?

RP: Yes, I think so. I think so. I think the athletes just need to keep in mind that the biological passport is a completely different animal [to standard anti-doping tests]. It is a fingerprint, it will always be there. Being part of the biological passport basically means that you are under scrutiny from the first blood test you ever had.

When you are compiling a body of knowledge, it takes time.

CT: Presumably if you have got a case where a rider is doping at isolated periods, it does take time for that data to build up and for you to be able to say, ‘this is probably your baseline, so these are the values that are unusual.’

RP: Exactly. And it could take twelve months to find a pattern like that. There may be a race where, ‘okay, this looks unusual, let’s follow the next two or three races. Okay, that looks pretty normal,’ then bang, you see another pattern emerging. Then you can say, ‘this rider appears to be targeting this particular race.’ And that happens quite often, they do target particular races.

CT: If we consider the periods in question – you have March 2011 until August 2011, which would take in the Classics and the Giro and/or the Tour, then in 2012 you have got a period from April until the end of the Giro d’Italia. Again you have a peak with a stage race. So I guess it may be the case that the first time they say, ‘okay, this is interesting, let’s watch him again,’ then you see a similar peak a year later and they know that something may be indeed amiss. So they may not necessary act on the first instance, but on the second….

RP: Yes, exactly.

CT: Looking at the overall biological passport system, would you say there are one or two cases in the system at any one point in time, or are there generally more than that?

RP: I have been working on one recently. There are many that are probably between the first and second stage, the initial assessment and the second opinion. They will be in the melting pot. The next step would be to have a teleconference. I don’t know how many there are at that stage, so there will be a few…

CT: And presumably some of those will not proceed further?

RP: Yes, that’s right.

CT: Is it true that there are extra safeguards built in, in terms of margins of error that usually will take out the grey area? In other words, when it gets to the point where an athlete is notified, is it fair to say that there is usually a fairly solid case?

RP: Well, as I said, to get that point there must be unanimous agreement between three experts. And I know from past experience that whenever there is one expert dissenting from the case, then it simply doesn’t go forward.

CT: So it has to be fairly solid to get this point – I guess that is the subtext?

RP: Yes, exactly.

To put it in context, remember Alberto Contador? We were dealing with a positive test, and that took a long time. This is no worse than that case, in a sense. He was notified and by the time that a result actually came out, it was well beyond 12 months.

CT: If we jump back to the Kreuziger case – the first period is March 2011 to August 2011. If we take it that a rider is going to be target tested after they show peculiar values, could this increase in testing prompt them to back off on what they are doing, at least for a while?

In that case, is it reasonable to think that this backing off is going to bring about changes to their biological passport, which will make it even more clear what is happening earlier?

RP: That is a very good observation [pauses]. You sort of don’t want to give the game away, if you know what I mean…but it is a very good observation..!

You see things and you say, ‘okay, we need to take a particular strategy with this….’